Merck-U02-Substudy 02D

What is the Purpose of this Study?

The study is divided into two periods: a screening period and a study dosing period.

If you choose to join this study, during the screening period you will:
- Have physical exams
- Have blood draws
- Have other tests done to assess your eligibility

The screening period will last for about one month.

If you are found to be eligible, you will continue on to the study dosing period. During this period, you will:
- Be randomly assigned (like a coin flip) to 1 of 2 groups
-- Group 1 will get MK-1308A (MK-1308 + pembrolizumab) and lenvatinib
-- Group 2 will get pembrolizumab and lenvatinib

Pembrolizumab and MK-1308 are given as intravenous (IV) infusions. Lenvatinib is a capsule that you take by mouth.
What is the Condition Being Studied?
Melanoma with Brain Metastasis (MBM)

Who Can Participate in this Study?

Adults ages 18+ who:

- Are diagnosed with stage IV melanoma

- Have metastasis to the brain

- Have not received more than 3 lines of previous therapies

For more information about who can join this study, please contact the study team at ivy.belskie@duke.edu.

Age Group
Adults
Participating Institutions

What is Involved?

We are doing this study to find out if different combinations of experimental drugs are safe and effective treatments for melanoma that has spread to the brain. We also want to know if there are biological markers, like your genes, that can help us predict how well the study drugs might work in the body to treat MBM.

Study Details

Full Title
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of
Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in
Participants With Melanoma-Substudy 02D
Principal Investigator

Protocol Number
IRB:
PRO00107693

NCT:
NCT04700072
ClinicalTrials.gov
View on ClinicalTrials.gov